By Taylor O’Bannon, Clara Diekman and Michelle Danyluk
In July 2024, the Food and Drug Administration (FDA) finalized changes to the Food Safety Modernization Act (FSMA) Produce Safety Rule Subpart E, which covers preharvest agricultural water. Since then, the clock has been ticking on farms’ implementation of the rule changes. Large farms have nine months after the effective date to comply. April 7, 2025, is when inspection of the changes goes into effect. Small farms have an additional year (2026), and very small farms have two additional years (2027) to implement the rule changes.
The major change to the rule for preharvest water is a shift away from water testing as a primary metric for making decisions about the quality of water. Preharvest water testing is no longer required under the rule.
Instead, an Ag Water Assessment (AgWA) must be completed for all pre-harvest agricultural water sources. This assessment goes beyond the Water System Inspection, which was already required to be completed and documented annually for each water source. The Water System Inspection still needs to be performed for all sources and distribution systems on the farm, including postharvest water sources, and is intended to be a separate inspection and record that informs the decisions made in the AgWA.
The AgWA replaces previous requirements of preharvest water testing for generic E. coli and calculating a Geometric Mean and Statistical Threshold Value from the test results. Instead, the AgWA takes into account the characteristics of the system, how the water is used, when it is applied, crop and environmental characteristics, and other factors (that can include testing results). At the end of the AgWA, growers must determine which of three primary categories their preharvest water fits into:
- No known or reasonably foreseeable hazards
- Conditions on adjacent or nearby land that may introduce reasonably foreseeable hazards related to animals, biological soil amendments or human waste
- Ag water that is not of safe or adequate quality for its intended use
Falling into the latter category requires immediate discontinuation of use and corrective measures. Corrective measures include reinspecting the entire system and making necessary changes or treating the water. The intermediate category, where conditions are present that may introduce hazards, requires mitigation measures. Mitigation measures include a reinspection and making necessary changes, increasing time between application of water and harvest, changing water application methods and treating the water.
While the decision-making is left up to growers to determine whether their water is of safe and adequate sanitary quality for its intended use, growers must be prepared to explain their conclusions during an inspection.
More information about the rule changes can be found on the FDA website or the Agricultural Water Assessment Fact Sheet. The FDA also has an Expanded Table on the Factors to Be Considered as Part of Agricultural Water Assessment that can inform the risks that may be assessed. Additionally, farms may use the FDA Ag Water Assessment Builder to answer questions and/or fill in information specific to their unique conditions.
On-Farm Readiness Reviews (OFRR) are another way growers can receive assistance implementing food-safety principles or the FSMA Produce Safety Rule on their farms. Visit www.fdacs.gov/OFRR to request an OFRR.
Contact UFFoodSafety@ifas.ufl.edu for more information about the FSMA Produce Safety Rule requirements or questions about proposed rule changes.
Taylor O’Bannon is a state food safety Extension agent, Clara Diekman is an education and training specialist, and Michelle Danyluk is a professor — all at the University of Florida Institute of Food and Agricultural Sciences Citrus Research and Education Center in Lake Alfred.
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